Asthma ChronicPhase 2NCT03736629
Azithromycin Treatment for the Airway Microbiome in Asthma
A Phase 2 study testing Azithromycin in people with Asthma Chronic, run by University of Chicago at 2 sites in United States.
Trial summary
The purpose of this study to determine whether the bacteria inside the lungs of people with asthma can be modified (changed) if they are given an antibiotic and if this change is associated with an improvement in asthma symptoms. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma Chronic
- What is being tested?
- Azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2019to 1 Jun 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 - 55 years
- Able to provide informed consent
- Smoking history < 10 pack-years
- Inclusion Criteria for subjects with poorly controlled asthma
- Methacholine PC20 < 16 mg/ml or PD 20 < 400 mcg/ml or albuterol response > 12% on FEV1 after 4 puffs of albuterol
- Currently prescribed ICS + LABA
- Meet definition for Th2-low asthma: peripheral blood eosinophil count < 300 and exhaled nitric oxide level < 30 ppb.
Who cannot join
- History of allergy or intolerance to any medications used in this study
- Medication exclusions:
- Current use of medications that prolong QTc interval
- Current use of omalizumab or other ant-IgE therapies
- Current use of anti-IL 5 therapies
- Current use of anticoagulants
Show all 15Show fewer
- Prednsione or other oral steroids within past 3 months
- Pregnancy or lactation, or plans to become pregnant
- Other respiratory or inflammatory disorders (e.g., sarcoidosis, emphysema)
- Pre-existing liver disease by history
- Smoking within the last 6 months
- Exacerbation of asthma in past 3 months
- Affected by a hearing disorder
- Clinically significant medical condition (e.g., heart failure, seizure disorder) which may in-crease risk as determined by study investigator
- Corrected QT interval > 450 msec. Patients with known cardiac history or prolonged QT interval on a screening EKG are excluded given the small but real potential for macrolide-related side effects
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University
Chicago, Illinois, 60201
University of Chicago
Chicago, Illinois, 60637
About this study
Official title: The AZITRAMBA Trial: Azithromycin Treatment for the Airway Microbiome in Asthma
The purpose of this study to determine whether the bacteria inside the lungs of people with asthma can be modified (changed) if they are given an antibiotic and if this change is associated with an improvement in asthma symptoms.
- Conditions
- Asthma Chronic
- Being tested
- Azithromycin, Placebo
- Keywords
- Asthma, Azithromycin, Microbiome, Sputum
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Also called Zithromax
8 weeks of Azithromycin (250 mg) once daily by mouth
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 8 weeks of placebo capsule once daily by mouth Receives: Drug: Placebo |
| Azithromycin | Active comparator | 8 weeks of Azithromycin (250 mg) capsule once daily by mouth Receives: Drug: Azithromycin |
| Non-asthmatic controls | No intervention | Non-asthmatic controls to assess variability of microbiome composition and diversity over time in a normal population. No intervention given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Test (ACT) Score Change From Baseline Over 8 Weeks
Score ranging from 0 to 40 indicating the degree of asthma symptoms. Lower score indicating worse asthma symptoms.
Measured: Baseline and 8 weeks
Secondary outcomes (7)
Forced Expiratory Volume (FEV1) Change From Baseline Over 8 Weeks
Volume of air exhaled in 1 second on a forced expiration, expressed as percent of predicted, indicating the degree of airflow obstruction in asthma
Measured: 8 weeks
Sputum Eosinophils Change From Baseline Over 8 Weeks
Percentage of 'eosinophils', an inflammatory cell seen in the airways of people with asthma, indicating the degree of inflammation
Measured: Baseline and 8 weeks
Sputum Neutrophils Change From Baseline Over 8 Weeks
Percentage of 'neutrophils', an inflammatory cell seen in the airways of people with asthma, indicating the degree of inflammation
Measured: Baseline and 8 weeks
Number of Participants With Diary Event or Serious Asthma Exacerbation Over 8 Weeks
The outcome is derived from a weighted scoring system called CompEx that describes asthma symptoms recorded on a daily basis. Final result is a dichotomous outcome indicating whether the patient had a "diary event" based on changes in peak expiratory flow, reliever use, and asthma symptoms or a serious exacerbation (deterioration of asthma leading to oral corticosteroid use, emergency room admission, or hospital admission).
Measured: 8 weeks
Microbiome Shannon Alpha-diversity Score Change From Baseline to 8 Weeks
A measure of the diversity of the bacteria in the sputum or oral sample; that is, how many different types of bacteria are present. This value decreases in severe asthma
Measured: 8 weeks
Microbiome Beta-diversity Score Change From Baseline to 8 Weeks
A second measure of the diversity of the bacteria in the sputum or oral sample; that is, how many different types of bacteria are present. This value decreases in severe asthma
Measured: 8 weeks
Microbiome Change in Relative Proportion of Top 10 Genera From Baseline to 8 Weeks
A measure of how many of the top types of bacteria are present in the sputum or oral sample. Value changes with asthma
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start1 Feb 2019
- Primary completion1 Mar 2021
- Study completion1 Jun 2022
Why it stopped: Inability to accrue patients, particularly after COVID pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma ChronicStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University
- Responsible party
- Sponsor
- Investigators
- Steve White, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736629
- Sponsor's protocol ID
- IRB17-1287
- Status last verified
- Aug 2023
- First submitted
- 7 Nov 2018
- Last updated
- 23 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share individual participant data that is de-identified available to all qualified investigators
Publications
Vogelmeier CF, Fuhlbrigge A, Jauhiainen A, Scheepers LEJM, Bengtsson T, Peterson S, Karlsson N, Sethi T, Locantore N, Tal-Singer R, Rennard S, Fageras M, Da Silva CA. COPDCompEx: A novel composite endpoint for COPD exacerbations to enable faster clinical development. Respir Med. 2020 Nov;173:106175. doi: 10.1016/j.rmed.2020.106175. Epub 2020 Sep 28.
PubMed 33032168
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The AZITRAMBA Trial: Azithromycin Treatment for the Airway Microbiome in Asthma
- ClinicalTrials.gov ID
- NCT03736629
- Acronym / sponsor ID
- IRB17-1287
- Conditions
- Asthma Chronic
- Keywords
- Asthma, Azithromycin, Microbiome, Sputum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to accrue patients, particularly after COVID pandemic.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Northwestern University
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 9 Nov 2018 (actual)
- Results
- Posted 23 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study to determine whether the bacteria inside the lungs of people with asthma can be modified (changed) if they are given an antibiotic and if this change is associated with an improvement in asthma symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo8 weeks of placebo capsule once daily by mouth |
| Azithromycin | Active comparator | Drug: Azithromycin8 weeks of Azithromycin (250 mg) capsule once daily by mouth |
| Non-asthmatic controls | No intervention | –Non-asthmatic controls to assess variability of microbiome composition and diversity over time in a normal population. No intervention given. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18 - 55 years
- Able to provide informed consent
- Smoking history < 10 pack-years
- Inclusion Criteria for subjects with poorly controlled asthma
- Methacholine PC20 < 16 mg/ml or PD 20 < 400 mcg/ml or albuterol response > 12% on FEV1 after 4 puffs of albuterol
Key exclusion criteria (15 listed)
- History of allergy or intolerance to any medications used in this study
- Medication exclusions:
- Prednsione or other oral steroids within past 3 months
- Pregnancy or lactation, or plans to become pregnant
- Other respiratory or inflammatory disorders (e.g., sarcoidosis, emphysema)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzithromycinAlso: Zithromax8 weeks of Azithromycin (250 mg) once daily by mouth | Drug | Azithromycin |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Asthma Control Test (ACT) Score Change From Baseline Over 8 Weeks
Time frame: Baseline and 8 weeks
Score ranging from 0 to 40 indicating the degree of asthma symptoms. Lower score indicating worse asthma symptoms.
7 secondary outcomes
Forced Expiratory Volume (FEV1) Change From Baseline Over 8 Weeks
Time frame: 8 weeks
Sputum Eosinophils Change From Baseline Over 8 Weeks
Time frame: Baseline and 8 weeks
Sputum Neutrophils Change From Baseline Over 8 Weeks
Time frame: Baseline and 8 weeks
Number of Participants With Diary Event or Serious Asthma Exacerbation Over 8 Weeks
Time frame: 8 weeks
Microbiome Shannon Alpha-diversity Score Change From Baseline to 8 Weeks
Time frame: 8 weeks
Microbiome Beta-diversity Score Change From Baseline to 8 Weeks
Time frame: 8 weeks
Microbiome Change in Relative Proportion of Top 10 Genera From Baseline to 8 Weeks
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33032168Vogelmeier CF, Fuhlbrigge A, Jauhiainen A, Scheepers LEJM, Bengtsson T, Peterson S, Karlsson N, Sethi T, Locantore N, Tal-Singer R, Rennard S, Fageras M, Da Silva CA. COPDCompEx: A novel composite endpoint for COPD exacerbations to enable faster clinical development. Respir Med. 2020 Nov;173:106175. doi: 10.1016/j.rmed.2020.106175. Epub 2020 Sep 28.
- Individual participant dataSharing planned: Yes. We will share individual participant data that is de-identified available to all qualified investigators
Related trials for Asthma Chronic
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Recruiting
THERMotherapy Against Persistent Bacterial LUNG Infections
Lung Diseases, Obstructive, Bronchiectasis
Not yet recruiting
Reducing Exposure With Air Cleaners and Technology
Asthma, COPD (Chronic Obstructive Pulmonary Disease)
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve White, MD principal investigator
University of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azithromycin in people with Asthma Chronic, run by University of Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Test (ACT) Score Change From Baseline Over 8 Weeks (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03736629, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.